Generate SOPs, Validations, Audits, HACCP, ISO, euGMP, GACP and GDP documents tailored to your facility. Manage Non-Conformances and correct them with your Quality Assistant. Guided by EMA guidelines.
No credit card required
From SOPs to full validation protocols — BasiDocs covers every GxP requirement
Quality Manuals, SOPs, Technical Instructions, Specifications, Document Control
IQ, OQ, PQ protocols, Computerised Systems (CSV/GAMP5), Cleaning & Process Validation
Full documentation for pharmaceutical and GxP producers — GACP cultivation, euGMP processing Parts I & II, industrial pharmaceutical manufacturing
Good Distribution Practice documentation for pharmaceutical and GxPs
Pharmaceutical HACCP — risk analysis, critical control points and validation for GxP facilities
ISO 9001, 13485, 14001, 22000 — full quality system documentation
Audit plans, reports, corrective actions, deviation management, non-conformances
Supplier qualification, CoA management, raw material specifications
CSV protocols, GAMP5, 21 CFR Part 11, audit trails, user requirements
Production, cleaning, maintenance, training records — full traceability
Process flowcharts, approval workflows, version control, change control
Your 24/7 quality consultant — ask anything about GxP compliance, audits, validations
From the first document to a complete quality system — all integrated, traceable and compliant.
The Assistant knows euGMP, GACP, GDP, GAMP5, ICH, Annex 11, 21 CFR Part 11 and all relevant ISO standards. You describe your facility — sector, certifications, equipment, processes — and it generates complete GxP documents adapted to your reality.
Document control compliant with euGMP Chapter 4 and Annex 11. Complete approval workflow: Draft → Under Review → Approved → Obsolete. Automatic versioning, review dates, full traceability.
Complete quality management workflow per ICH Q10, euGMP Chapter 8 and GAMP5. When you detect a deviation or NC, the system automatically creates the corresponding CAPA with full traceability — from origin to effectiveness verification.
Immutable record of all platform actions — who did what, when. SHA-256 hash for integrity verification. PDF export with digital signature. Compliant with Annex 11 (EU), 21 CFR Part 11 (FDA) and GAMP5.
COMPLETE TRACEABILITY FLOW
Every action recorded with timestamp, user and SHA-256 hash
Available 24/7, with deep knowledge of EMA, GACP, GDP, ICH and all major GxP guidelines
Try for freeWe know the industry from the inside. We have lived through audits, validations and regulatory submissions. BasiDocs was born from the frustration with complex, expensive and time-consuming documentation — and the certainty that it could be better.
With over 8 years of real experience in the pharmaceutical and GxP sector, we built a platform that combines specialized regulatory knowledge with cutting-edge technology — so your company always has the right documentation, at the right time.
Facility layouts, formulas, methods and security plans are critical information. We treat them with the utmost rigour.
All documents encrypted at rest and in transit. Nobody accesses your files without authorization.
Upon registration, you automatically sign a confidentiality agreement. Your data is our secret.
Your data is never used for advertising or shared with third parties. Ever.
Record of who accessed, changed or approved each document. Compliant with 21 CFR Part 11 and Annex 11.
Each company's data is completely isolated. It is impossible to access another company's data.
Delete all your data at any time. We fully comply with GDPR.
🔒 Your documents, facility layouts, formulas and data are stored in an encrypted and completely isolated environment. Only you have access. They are never shared, sold or used for any purpose other than the operation of your account. BasiDocs is more secure than your email.
What our customers say
"BasiDocs cut our SOP creation time from days to minutes. The quality is outstanding and fully aligned with EMA guidelines."
Start free. Scale as you grow.
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For small facilities
🚀 Launch offer — €149/month for 1 year
For large facilities & groups
Full on-site consulting & implementation
Travel & accommodation not included.
Contact usNo subscription needed. Buy credits and use them whenever you need. VAT included.
Full transparency on what's done and what's coming next.
Have a feature idea? Tell us — the best suggestions make it into the roadmap.
Join facilities already using BasiDocs. Start with 1 free document.
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